MDR and IVDR Highlighted at RAPS Regulatory Convergence

    While attending the recent RAPS Regulatory Convergence in Philadelphia, PA, U.S., we were able to get a sense of some of the upcoming trends in regulation.

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    In an effort to better understand and also stay current with the issues our medical device clients face, Amplexor Life Sciences strives to perpetually continue the learning process. One way to do this is through relevant conference attendance.

    Over a period of three days in late September, the Amplexor team attended the RAPS Regulatory Convergence in Philadelphia, PA, United States. During the conference, our team was able to attend multiple sessions and increase our company’s knowledge on MDR and IVDR, as well as new trends in AI and machine learning.

    Hot Takes on MDR and IVDR Regulation

    At RAPS, it was clear that MDR and IVDR continue to be top-of-mind for medical device professionals. With sessions on everything from EU medical device regulations to reviewing and in an evaluation report, the focus of the conference seemed to be on preparing for upcoming regulation changes. The knowledge and expertise shared at RAPS Convergence will help Amplexor stay current with the concerns of our clients as they relate to MDR and IVDR.

    AI and Machine Learning

    In addition to keeping up to date with MDR and IVDR, Amplexor prioritizes staying current with the trends and challenges in artificial intelligence (and machine learning.

    The digital explosion in healthcare is a complex and ever-evolving topic. One thing all RAPS attendees agreed on is while technological advancements are critical, the focus must never shift from what is best for the patient.

    As an industry leader when it comes to technology and content strategy, Amplexor is helping our pharma and device customers offer optimal patient care, with outside-the-box thinking to apply AI whenever and wherever possible.

    One way we do this is through creation, publishing and translation of regulatory content. RAPS Convergence provided the Amplexor team the opportunity to hear from device manufacturers that the most challenging area of the new regulation will likely be related to Clinical Data.

    Amplexor is proactively partnering with our device clients to optimize content to reuse for the MDR and IVDR regulation deliverables. Due to the high level of repetition between the device IFUs and other reference content in the SSCP, Amplexor’s goal is to apply intelligent content analysis to the process.

    With a goal of facilitating the re-use of content beyond what is possible with translation software alone, we aim to bring the AI capability further upstream during the content authoring stage. Our device customers further benefit when IFU and SSCP updates are needed. Updates can be optimally managed with a defined content analysis approach. Amplexor estimates the impact to time and cost savings could be significant for device manufacturers.

    To learn more about Amplexor’s commitment to growth in order to offer our customers the best service possible, please reach out to us.








    Published on    Last updated on 12/11/2019

    #Life Sciences, #Artificial Intelligence, #Linguistic Validation, #Translation & Localization

    About the author

    Kathleen O’Brien is Director of Business Development with Amplexor Life Sciences and a 15-year veteran of the translation industry. Kathleen has a background in linguistics and has held various roles in the translation business: vendor, project and account management, as well as new business development, giving her a unique perspective into both translation operations and how translation impacts the globalization needs of her clients in the pharmaceutical and medical device industries. She proactively collaborates with her life sciences client partners on a daily basis to help them set their localization strategies.